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Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

NCT03549988 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 726

Last updated 2026-05-01

No results posted yet for this study

Summary

Hypothesis:

Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

Conditions

Interventions

OTHER

Fecal Calprotectin (FC) measurements with IBDocTM

Each IBDocTM kit measure one fecal calprotectin value. The IBDoc® is an in-vitro diagnostic immunoassay analyzed by a downloadable smartphone application (CalApp®). A patient is able to process their stool at home using a test cassette. The IBDocTM test results are displayed in a light signal system as three titre categories; normal \<100 µg/g (green), 100-300 µg/g (yellow), \>300 µg/g (high). Patients' results will be sent directly to the central research coordinator through the IBDoc® Web Portal. If the FC is \>250 µg/g a second FC will be performed within 2 weeks. If this result is \<250 µg/g patients will continue to monitor their FC every 2 months. If the second result is \>250 µg/g, the attending physician will review the patient either by telephone or in the office within 7 days.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Gregory Rosenfeld, MD · University of British Columbia, Depart. of Medicine, Div. of Gastroenterology

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2025-12-30
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549988 on ClinicalTrials.gov